Manufacturing Of Sterile Pharmaceutical Products

Question 1

What is aseptic production?

Answer 1

Medicine, container and closure sterilised separately

Question 2

What are the BP accepted sterilisation processes?

Answer 2

Steam 
Dry heat 
Ionising radiation 
Gaseous sterilisation 
Filtration

Question 3

How does steam sterilisation work and what on?

Answer 3

By saturated steam under pressure in autoclave

Used for bottled aqueous solutions, containers, dressing, instrument

Question 4

How does dry heat work and what on?

Answer 4

In hot air oven

Glass bottle and metal surgical instruments

Question 5

How does Ionising radiation work and on what?

Answer 5

Accelerated electrons or gamma rays which cause DNA damage

Ointments, instruments and sutures

Question 6

How does gaseous sterilisation work? And what on?

Answer 6

Ethylene oxide and formaldehyde cause chemical modification of proteins and nucleic acid

Powders and instruments

Question 7

How do filtration of solutions and gases work?

Answer 7

Removal of particles requires laminar flow cabinet

Sterile air using high efficiency particulate air filters

Question 8

What is terminal sterilisation?

Answer 8

Product manufactured and sealed in container then sterilised

Question 9

How is sterility controlled?

Answer 9

Incubation of whole or portion of products with a nutrient medium to verify absence of contamination

Question 10

What is sterility assurance?

Answer 10

Working in clean environment

Following GMP/GWP

using contamination free starting materials
Suitable packaging and storage